Recruiting

Hormone TherapyHormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

Sponsor:

University of Calgary

Code:

NCT05442463

Conditions

Hormone Therapy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Captopril Tablets

Iohexol

Study Details

Brief summary:

1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

Conditions

Hormone Therapy

Study ID

NCT05442463

Start date

Nov 30, 2020

Status verified date

Mar, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Age 18 to 90 years
Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)

Exclusion Criteria:

Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
Cerebrovascular disease (transient ischemic attacks or stroke)
History of hypertension (BP>140/90 or use of antihypertensive medications)
Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose >7mmol/L)
Current smoker
Previous history of preeclampsia
Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cisgender and transgender women

Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally.

Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing.

Cisgender and transgender men

Interventions

Captopril Tablets

Captorpril challenge to each participant

Iohexol

Iohexol infusion to evaluate measured GFR

Primary outcome measure

First association in transgender women and cis women [ Time Frame: 2025 ]
Second association in transgender men and cis men [ Time Frame: 2025 ]

Central Contacts and Locations

Central contacts

Darlene Y Sola, BScN

4032107434 dsola@ucalgary.ca

Victoria Riehl-Tonn, BN

4032109434 victoria.riehltonn@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Darlene Y Sola, BScN

4036149431 dsola@ucalgary.ca

Victoria Riehl-Tonn, BN

4036149431 victoria.riehltonn@ucalgary.ca

Principal Investigator:

Sofia Ahmed, MD

More Information

Sponsor

University of Calgary

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

post menopausal hormone replacement therapy
transgender men
transgender women
nonbinary
cis gender
post menopause
HRT
hormone replacement therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-03-27.